Here is the checklist and format of documents required for new drug product registration, company registration, Import of Radioactive Substances and Import of Intra OcularLenses (IOL) in Nepal. This checklist has developed by the Department of Drug Administration (DDA).
Checklist for Company Registration
S.No.
Document required
1
Application by the importer for Company registration
2
Application by the Company on its letterhead
3
Letter of Authority to the importer
4
Site Master File (as per PICS guidelines/WHO Guidelines)
5
Notarized Copy of Up to date manufacturing license
6
List of Products Intended to be registered in Nepal
7
Letter of Warranty (Annex 3)
8
Latest GMP internal audit report
9
Photocopy of updated Wholesale registration
10
Complete Dossier of one product intended to register
11
WHO GMP certificate from concern regulatory authority
12
Product registration and market authorization in SRA countries
13
REMS (Risk Evaluation and Mitigation Strategy)including PV(Pharmacovigilance) and post Marketing Surveillance
14
Approval letter from DDA on WHO GMP compliance (applicable for Non-SRA, Non UN prequalified products and company
Checklist for Product Registration
S. No.
Document required
1
An application in the form of Schedule 4 ‘C’(DDA document)
2
An application in the form Schedule 6 (DDA document)
3
Notarized Up-to-date manufacturing license issued
4
Notarized Copy of Valid COPP as recommended by WHO
5
Detail formulation including excipients, colour, flavour, etc
6
In case of new drug combination / new molecule (document in the format designed by the Department).
7
BA/BE if non pharmacopeial and modified release
8
Product Specification
9
Method of Analysis
10
Monograph if pharmacopoeia
11
Analytical Method Validation if non pharmacopoeia
12
Samples of label and carton
13
Sample of the product
14
Analytical report from Company’s own laboratory
15
Analytical report from independent laboratory (authorized)
16
Real time stability (Zone IVb) of two batches for claimed shelf life
17
Letter of Attorney (Annex 5)
18
Price commitment for lower price than exporting company
19
Comparative Price of at least 5 bands if available
20
Company inspection report of DDA if audited
Checklist for Product Renewal
S. No.
Document required
1
Application for renewal of 4 E and 7
2
Original 4 E and 6
3
Notarized COPP
4
Notarized Valid Mfg. Lic
5
Notarized Valid GMP
6
Sample
7
Annual Product Review
8
Stability information
9
Declaration on ADR
10
Price to importer, wholesaler, retailer and MRP
11
Approval of variation made under the period
12
Evidence of export to SRA in case of company registered under SRA export
13
COA ( Certificate of analysis)
Documents Required for Import of Intra Ocular Lenses(IOL)
S. No.
Document required
1
Application by Importer
2
Application by Company
3
Manufacturing License
4
Site Master File (SMF)
5
ISO 9000 : 2000 Certificate
6
EC Directives 93/42/EEC Annex II-CE Certification
7
ISO 13485 : 2003 (Quality Management System of the Industry)
8
ISO 11979 : 1999 (Standard of the Product)
9
Quality Manual
10
Sources of the Materials used in the Lens
11
Authority Letter from the Manufacturer
12
Test Report of the Lens
13
Letter of Warranty
14
Unit Price
Documents Required for Import of Radioactive Substances
S. No.
Document required
1
Application by Importer
2
Industry Registration Certificate
3
Company Registration Certificate.
4
Approval letter from Government Agency for handling radioactive substances
5
Material Safety Data Sheet
6
Performa Invoice
7
License from authorized Atomic Energy Regulatory Board
8
Standard Operating Procedures for Transport, Handling, Storage and Disposal
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